BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 32IDX50OD

    MDR report key: 3940596 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23654
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. THE RETURNED FEMORAL HEAD EXHIBITS SIGNS OF COMING INTO DIRECT CONTACT WITH THE ACETABULAR CUP, FURTHER SUPPORTING THE DISASSOCIATION. IN THIS CASE 4 OF THE ARD'S OF THE POLYETHYLENE LINER HAVE FRACTURED. IT IS EVIDENT THAT THE EDGE OF THE LINER WAS LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT WHILE IMPLANTED. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. THE EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED LEADING TO A FRACTURE OF THE MATERIAL AND SUBSEQUENT DISASSOCIATION OF THE LINER FROM THE CUP. NO PATIENT DEMOGRAPHICS HAVE BEEN MADE AVAILABLE. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS NECESSARY REVISION SURGERY DUE TO EARLY WEAR OUT OF THE PINNACLE MARATHON POLYETHYLENE. IT WAS IMPLANTED TWO YEARS AGO SO IT WAS REPLACED. THIS CAUSED THAT THE CERAMIC HEAD WAS WORN OUT SO THE PATIENT SUFFERED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419545 PINN MAR +4 10D 32IDX50OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC.1818910 FC6KG1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention